CAPTEK® Softgel International · 4 weeks ago
Quality Systems Analyst
Vista, CA
Full-time
Onsite
Mid Level
3+ years expCAPTEK® Softgel International is seeking a Quality Systems Analyst responsible for monitoring and improving the compliance of quality systems and manufacturing processes. The role involves managing Batch Record Reviewers, driving improvements in compliance, and ensuring productivity in line with applicable regulations and standards.
Manufacturing
Responsibilities
Analyzes continuous improvement of the factory internal quality audit program, and monitors trends to solve chronic issues
Develops Corrective Action and Preventive Action (CAPA) plans to lead continuous improvement initiatives
Collaborates with supervisors and managers in effort to address findings and implement improvement projects
Oversees on-time closure of assigned deviations and analyzes CAPA system for trends and effectiveness
Documents results of new procedures after implementation to show quality improvements
Develops and implements test procedures to obtain the defect information needed for analysis and report findings from test and inspection data to management
Analyzes quality inspection data to identify quality problems and perform root cause analysis
Initiates quality related investigations and supports deviation documentation process utilizing the company’s electronic database system
Assists in collecting and reporting weekly and monthly Quality reports, e.g., First Pass Quality (FPQ), quality complaints, Non-Conformance Report (NCR), deviations, and others as assigned
Makes recommendations to improve the production process based on findings from quality assurance analysis of the FPQ results
Monitors improvement procedures to determine if changes significantly improve the process and the defect quantities
Creates new processes or modifies and improve current processes by setting up clear and definite quality systems and SOPs
Monitors quality compliance with the company’s standard operating procedure requirements and applicable regulations
Collaborates across multiple disciplines and interfaces closely with our Operations, Distribution, R&D, Technical services and Procurement teams
Participates in multi-function team activities, support and maintain Quality Systems and perform other assignments as directed by Manager
Qualification
Required
Excellent knowledge of Quality Management Systems (NCR, CAPA, Deviations, Document Control, Audits, etc.)
Excellent Problem solving and statistical skills using quality tools (Pareto analysis, statistical process control, multi-variant DOE etc.)
Knowledge of regulatory and compliance requirements such as 21 CFR Part 111
Experience in project planning, and project management
Proficient with Microsoft Excel, PowerPoint and Microsoft
Excellent written and verbal communication, presentation and interpersonal skills
Strong understanding of sampling techniques
Experience in process capability studies
Experience in process and equipment validation
3-5 years of experience in the food, pharmaceutical and/ or supplement industry
Preferred
Six Sigma green belt or higher
Working HACCP knowledge
Certified Quality Auditor
Bachelors in Pharmaceutical, Food Science, Chemical Engineering, Chemistry or other Science related field
ASQ CQE or CQM
Company
CAPTEK® Softgel International
Established in 1996, CAPTEK® Softgel International Inc.
501-1000 employees
H1B Sponsorship
CAPTEK® Softgel International has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
unknown2015-12-14Acquired
Leadership Team
Brett Buatti
CEO
P
Paul Anton
Chief Financial Officer
Recent News
Mergers & Acquisitions
2025-10-23
Morningstar.com
2025-10-22
Company data provided by crunchbase